Gao Xiangjin, Ding Yuning, Cai Ruiqi, Zhang Xiuqi, Duan Zhen, Xu Quanruo, Shen Fanlingzi, Li Siyuan, Zhang Rui, Wang Ruiping
Clinical Research Center, Shanghai Skin Disease Hospital, Shanghai, China.
School of Medicine, Tongji University, Shanghai, China.
JMIR Res Protoc. 2025 Jul 2;14:e77927. doi: 10.2196/77927.
Atopic dermatitis (AD) is a recurrent, inflammatory, and chronic skin disease that influences over 200 million individuals around the world and is viewed as an important health problem due to its elevated prevalence, long course of disease, and heavy disease burden. WuSheZhiYang (WSZY) pills are composed of 11 Chinese herbs and have the effects of nourishing the blood, drying dampness, and relieving itching. In clinical practice, WSZY pills are recommended for itching skin diseases, but high-quality clinical trial evidence is still limited.
In this study, we will implement a double-blind, randomized, placebo-controlled trial to evaluate the efficacy of WSZY pills for mild-to-moderate AD. We hypothesized that WSZY pills can effectively alleviate the disease condition of patients with mild-to-moderate AD.
In this study, we will recruit 60 patients with mild-to-moderate in Shanghai Skin Diseases Hospital from December 2024 through December 2025. In this study, 60 male and female patients with AD aged 18 years to 65 years will be randomly assigned (2:1) to the treatment group (urea ointment and WSZY pills; n=40) or control group (urea ointment and placebo WSZY pills; n=20), and both groups will receive 4 weeks of treatment and 4 weeks of follow-up. The treatment group will receive 3 sessions of urea ointment and 7.5 g of WSZY pills each day for 4 weeks, and the control group will also receive 3 sessions of urea ointment and 7.5 g of placebo WSZY pills each day for 4 weeks. The primary indicator is the change in the objective Scoring Atopic Dermatitis (SCORAD) score between baseline and week 4. The secondary indicators include SCORAD at week 2 and week 8; Peak Pruritus Numerical Rating Scale (PP-NRS), Investigator's Global Assessment (IGA), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI) at week 2, week 4, and week 8; and the proportion of participants receiving remedial treatment, amount of levocetirizine tablets used, and recurrence rate at week 8. In this study, we will analyze the full analysis set and per-protocol set using SAS software version 9.4, and a 2-tailed alpha level of .05 will be viewed as statistically significant.
The study received ethics permission in September 2024, and trial registration was completed in October 2024. Recruitment started in December 2024 and is expected to be completed by December 2025. As of June 2025, 30 participants with mild-to-moderate AD were enrolled. Data analysis will begin in January 2026. The main results of the trial are expected to be submitted for publication in peer-reviewed scientific journals in the summer of 2026.
This study will evaluate the efficacy of WSZY pills for AD and provide additional evidence, suggest new therapeutic options for patients, and reduce their disease burden.
International Traditional Medicine Clinical Trial Registry ITMCTR2024000724; http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=bda070f8-a733-4f52-87b0-39e4be57ac00.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/77927.
特应性皮炎（AD）是一种复发性、炎症性慢性皮肤病，全球有超过2亿人受其影响。由于其患病率不断上升、病程长且疾病负担重，被视为一个重要的健康问题。乌蛇止痒丸由11味中药组成，具有养血、燥湿、止痒的功效。在临床实践中，乌蛇止痒丸被推荐用于治疗瘙痒性皮肤病，但高质量的临床试验证据仍然有限。
在本研究中，我们将开展一项双盲、随机、安慰剂对照试验，以评估乌蛇止痒丸治疗轻至中度AD的疗效。我们假设乌蛇止痒丸能有效缓解轻至中度AD患者的病情。
本研究将于2024年12月至2025年12月在上海市皮肤病医院招募60例轻至中度患者。本研究将把60例年龄在18岁至65岁之间的AD患者（男女不限）随机分配（2:1）至治疗组（尿素软膏和乌蛇止痒丸；n = 40）或对照组（尿素软膏和乌蛇止痒丸安慰剂；n = 20），两组均接受4周治疗和4周随访。治疗组每天接受3次尿素软膏和7.5 g乌蛇止痒丸治疗，持续4周，对照组每天也接受3次尿素软膏和7.5 g乌蛇止痒丸安慰剂治疗，持续4周。主要指标是基线至第4周时客观特应性皮炎评分（SCORAD）的变化。次要指标包括第2周和第8周的SCORAD；第2周、第4周和第8周的瘙痒峰值数字评定量表（PP-NRS）、研究者整体评估（IGA）、患者导向性湿疹测量（POEM）和皮肤病生活质量指数（DLQI）；以及接受补救治疗的参与者比例、左西替利嗪片使用量和第8周的复发率。在本研究中，我们将使用SAS软件9.4版分析全分析集和符合方案集，双侧α水平为0.05将被视为具有统计学意义。
该研究于2024年9月获得伦理许可，并于2024年10月完成试验注册。招募工作于2024年12月开始，预计于2025年12月完成。截至2025年6月，已招募30例轻至中度AD患者。数据分析将于2026年1月开始。试验的主要结果预计将于2026年夏季提交至同行评审的科学期刊发表。
本研究将评估乌蛇止痒丸治疗AD的疗效，并提供更多证据，为患者建议新的治疗选择，减轻其疾病负担。
国际传统医学临床试验注册中心ITMCTR2024000724；http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=bda070f8-a733-4f52-87b0-39e4be57ac00。
国际注册报告识别码（IRRID）：DERR1-10.2196/77927。
